FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
MEDELA VARIO SUCTION PUMPS
K Number: K061435
·
Decision Jun 8, 2006
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
204
Applicant Total
19
Review Days
15
Basic Information
- Device Name
- MEDELA VARIO SUCTION PUMPS
- K Number
- K061435
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4780
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MEDELA AG
- Date Received
- May 24, 2006
- Decision Date
- June 8, 2006
- Product Code
- OMP
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | FDA class 2 | General, Plastic Surgery |
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|---|---|---|---|
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| K150499 | Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor Warranty | Apr 21, 2015 | Substantially Equivalent |
| K150134 | Basic, Dominant Flex, KV-6 | Apr 21, 2015 | Substantially Equivalent |
| K141926 | INVIA ENDURE NEGATIVE PRESSURE WOUND THERAPY SYSTEM | Dec 19, 2014 | Substantially Equivalent |
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| K130123 | BASIC AND DOMINANT FLEX SUCTION PUMPS | Oct 11, 2013 | Substantially Equivalent |
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| K113678 | INVIA MOTION NEGATIVE PRESSURE WOUND THERAPY SYSTEM | Oct 1, 2012 | Substantially Equivalent |
| K080357 | MEDELA INVIA WOUND THERAPY | Jul 24, 2008 | Substantially Equivalent |